Giulia Bugani1, Matteo Pagnesi2, Didier Tchetchè3, Won- Keun Kim4, Arif Khokhar5, Jean- Malte Sinning6, Uri Landes7, Ran Kornowski7, Pablo Codner7, Ole De Backer8, Georg Nickenig6, Alfonso Ielasi9, Chiara De Biase3, Lars Søndergaard8, Federico De Marco10, Marco Ancona2, Matteo Montorfano2, Damiano Regazzoli11, Giulio Stefanini11, Stefan Toggweiler12, Corrado Tamburino13, Sebastiano Immè14, Giuseppe Tarantini15, Horst Sievert16,17, Ulrich Schäfer18, Jörg Kempfert19, Jochen Wöehrle20, Maurizio Tespili9, Alessandra Laricchia5, Azeem Latib21,22, Francesco Giannini5, Antonio Colombo5,23, Antonio Mangieri24. 1. Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Ferrara, Italy. 2. San Raffaele Scientific Institute, Milan, Italy. 3. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. 4. Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany. 5. Interventional Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, via della Corriera 1, 48033, Cotignola, Ravenna, Italy. 6. Cardiology Department, University Hospital Bonn, Bonn, Germany. 7. Cardiology Department, Rabin Medical Center, Petah Tikva, Israel. 8. The Heart Center-Rigshospitalet, Copenhagen, Denmark. 9. Istituto Clinico Sant'Ambrogio, Milan, Italy. 10. Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy. 11. Clinical and Interventional Cardiology Unit, Cardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy. 12. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland. 13. Cardiology Division, CAST Policlinico Hospital, University of Catania, Catania, Italy. 14. Centro Cuore Morgagni, Catania, Italy. 15. Interventional Cardiology Unit, University of Padova, Padua, Italy. 16. Cardiovascular Center Frankfurt, Frankfurt, Germany. 17. Anglia Ruskin University, Chelmsford, UK. 18. UKE Hamburg, Hamburg, Germany. 19. Deutsches Herzzentrum Berlin, Charité Universitätsmedizin, Berlin, Germany. 20. Ulm University, Ulm, Germany. 21. Department of Cardiology, Montefiore Medical Center, New York, NY, USA. 22. Division of Cardiology, Department of Medicine, University of Cape Town, Cape Town, South Africa. 23. EMO GVM Centro Cuore Columbus, Milan, Italy. 24. Interventional Cardiology Unit, GVM Care and Research, Maria Cecilia Hospital, via della Corriera 1, 48033, Cotignola, Ravenna, Italy. antonio.mangieri@gmail.com.
Abstract
OBJECTIVES: To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality. BACKGROUND: Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking. METHODS: The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure. RESULTS: Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p < 0.0001) and higher baseline aortic mean gradients (57.6 ± 13.4 mmHg vs. 47.7 ± 16.6, p = 0.013) and more often presented with BAV of Sievers type 0 than patients without HRG. At multivariate analysis, BMI [odds ratio (OR) 1.12; 95% confidence interval (CI) 1.05-1.20, p = 0.001] and BAV type 0 (OR 11.31, 95% CI 3.45-37.06, p < 0.0001) were confirmed as independent predictors of high gradient. CONCLUSION: HRG following TAVR in BAVs is not negligible and is higher among patients with high BMI and with BAV 0 anatomy.
OBJECTIVES: To define the incidence of high residual gradient (HRG) after transcatheter aortic valve replacement (TAVR) in BAVs and their impact on short term outcome and 1-year mortality. BACKGROUND: Transcatheter heart valves (THVs) offer good performance in tricuspid aortic valves with low rate of HRG. However, data regarding their performance in bicuspid aortic valves (BAV) are still lacking. METHODS: The BEAT (Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry included 353 consecutive patients who underwent TAVR (Evolut R/PRO or Sapien 3 valves) in BAV between June 2013 and October 2018. The primary endpoint was device unsuccess with post-procedural HRG (mean gradient ≥ 20 mmHg). The secondary endpoint was to identify the predictors of HRG following the procedure. RESULTS: Twenty patients (5.6%) showed HRG after TAVR. Patients with HRG presented higher body mass index (BMI) (30.7 ± 9.3 vs. 25.9 ± 4.8; p < 0.0001) and higher baseline aortic mean gradients (57.6 ± 13.4 mmHg vs. 47.7 ± 16.6, p = 0.013) and more often presented with BAV of Sievers type 0 than patients without HRG. At multivariate analysis, BMI [odds ratio (OR) 1.12; 95% confidence interval (CI) 1.05-1.20, p = 0.001] and BAV type 0 (OR 11.31, 95% CI 3.45-37.06, p < 0.0001) were confirmed as independent predictors of high gradient. CONCLUSION: HRG following TAVR in BAVs is not negligible and is higher among patients with high BMI and with BAV 0 anatomy.